Search results with tag "Modified release products"
Guideline on quality of oral modified release products
www.ema.europa.eumanipulation of modified release products may adversely affect the modified release properties of the dosage form, possibly leading to dose dumping. Any recommendation on subdivision of a modified release dosage form should be supported by scientific justification that the subdivision does not affect the
Crushing guide for oral medication - SafeRx
www.saferx.co.nzIf modified release products are crushed, the whole dose will be released very quickly and could be dangerous. Modified release products should never be crushed or modified. Dispersing tablets or capsule contents3 If tablets or capsules are able to be dispersed, it is best to put the tablet (or capsule contents) into mortar or medicine cup. Then
ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …
asean.orgeg. Modified release products, transdermal products and orally inhaled products etc, refer to relevant guidelines as stated below. The scope is limited to chemical entities. Recommendation for the comparison of biologicals to comparator medicinal products can be found in guidelines on similar biological medicinal products.
Guideline on the quality of Transdermal Patches
www.ema.europa.euThis guideline together with the new Guideline on Quality of Oral Modified Release Products replaces the “Note for Guidance on Modified Release products: A: Oral dosage Forms B: Transdermal Dosage Forms. Part I (Quality)” (CPMP/QWP/604/96). Keywords Transdermal patch, adhesives, dissolution, skin permeation